Depression
Conditions
Keywords
ketamine, esketamine, virtual reality
Brief summary
Investigators aim to examine the role of audiovisual inputs during treatment with ketamine/esketamine in affecting tolerability and effectiveness of treatment of depressive episodes, by providing patients with a relaxing environment using virtual reality goggles and noise cancelling headphones, and assessing whether these tools can improve the tolerability and effectiveness of treatment with ketamine/esketamine
Interventions
DEVICEVirtual reality
Virtual reality gear and content will be used to affect and control the audiovisual perception of patients during a single treatment with ketamine/esketamine
Sponsors
Yale University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants must be at least 18 years old * Patients must have completed the acute series of treatment and weekly optimization phases of ketamine/esketamine treatment, and currently receiving continuation/maintenance treatment Written consent for the study procedures * Ability and willingness, in the investigator's judgement, to comply with the study procedure and study requirements.
Exclusion criteria
* Hearing or visual impairment to the degree that would interfere with ability to see or hear VR content. * Difficulty in understanding spoken or written English * Unable to provide informed consent * Dementia or other cognitive disorder or intellectual disability that would impair the subject's ability to understand the study procedure (per investigator judgment) * Any other medical or psychiatric comorbidity that the investigator judges would put the participant at additional undue risk due to study participation or would impair subject's ability to participate in the study. * Was previously enrolled/randomized into the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability of VR Treatment Assessed by Qualitative Report | Immediately post-VR treatment | Tolerability of VR treatment will be assessed by qualitative report, an open-ended question where the participant is allowed to describe any concerns not covered by SAFTEE assessment. Data presented here is the number of participants that stated the treatment was Tolerated. |
| Safety of VR Treatment Assessed by Systematic Assessment of Treatment Emergent Events (SAFTEE) Assessment | baseline up to Immediately post-VR treatment | The SAFTEE assessment will be used to assess adverse events during the trial by the number of participants that had any adverse events while on study. |
| Change in Overall Treatment Experience Satisfaction | Baseline, during and immediately post VR treatment session | Efficacy will be assessed by the difference in overall treatment experience satisfaction (via Likert scale) between the pre-VR and VR treatment sessions. Total scores range from 0 to 10 with higher scores indicating higher satisfaction with the treatment experience. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in 5-Dimensional Altered States of Consciousness Questionnaire (5D-ASC) Subscale Scores | baseline, during VR treatment and Immediately post-VR treatment | The 5D-ASC measures altered states of consciousness and contains 94 items using visual analogue scales. Score for each will be calculated from 0 to 100 based on measurement of where the participant has drawn the line. Then each subscale is the median score from a pre-defined list of items (eg subscale 2 is median of items 9,81,94). Higher scores means more altered state of consciousness. |
| Change in 5D-ASC Total Score | baseline, during VR treatment and Immediately post-VR treatment | The 5D-ASC measures altered states of consciousness and contains 94 items (visual analogue scales. Score for each will be calculated from 0 to 100 based on measurement of where the participant has drawn the line. Total score is the median of all items. Higher scores means more altered state of consciousness. |
| Change in The Clinician-Administered Dissociative States Scale (CADSS) | baseline, during VR and immediately post VR treatment | The CADSS is a 23 item structured clinical interview to assess state dissociation rated by clinicians. Each item is scored from 0 (not at all) to 4 (extreme). Total score range from 0-92 with higher scores indicating greater severity of dissociative experiences. |
| Change in Participant Experience | baseline, during VR treatment and Immediately post-VR treatment | Participant experience will be assessed by self report on whether it was a "pleasant vs unpleasant experience"using a Likert scale. Scores from 0-10 with higher scores indicating a more pleasant experience. |
| Change in Level of Relaxation | baseline, during VR treatment and Immediately post-VR treatment | The "level of relaxation" will be scored using a Likert scale with total score range from 0 to 11. Higher scores indicate a higher level of relaxation. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSina Nikayin, MD
Assistant Professor, Departement of Psychiatry, Yale University
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 42.71 years STANDARD_DEVIATION 14.35 |
| Diagnosis Bipolar Disorder | 1 Participants |
| Diagnosis Major Depressive Disorder | 6 Participants |
| Education Bachelor's Degree | 2 Participants |
| Education Doctorate Degree | 2 Participants |
| Education High School | 1 Participants |
| Education Master's Degree | 1 Participants |
| Education Some College | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 2 Participants |
| Treatment Intervention Esketamine | 7 Participants |
| Treatment Intervention Ketamine | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 6 / 7 | 5 / 5 | 3 / 5 |
| serious Total, serious adverse events | 0 / 7 | 0 / 5 | 0 / 5 |
Outcome results
None listed